carboplatin and pemetrexed in recurrent platinum sensitive ovarian cancer

Conditions: Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Summary: the purpose of this study is to determine the effects (good and bad) the combination of carboplatin and pemetrexed have on patients with recurrent ovarian, peritoneal, or fallopian tube cancer.

* before patients receive any chemotherapy treatments they will be given three medications to prevent side effects from the chemotherapy drugs. these medications are vitamin b12, folic acid and dexamethasone. * chemotherapy treatments will be given intravenously in the outpatient clinic. pemetrexed will be given first and will take 10 minutes to infuse followed by carboplatin which will take 30-45 minutes to infuse. these treatments will be repeated once every three weeks for 6 cycles of chemotherapy (18 weeks). * before each chemotherapy treatment the following tests and procedures will be performed: physical exam and medical history; evaluation of ability to undertake daily activities; and blood tests. * after every 2 cycles of chemotherapy (every 6 weeks) patients will have a ct or mri scan to measure how well their cancer is responding to treatment. * the study treatment will last for 6 cycles of chemotherapy as long as the tumor does not grow and the patient isn't experiencing any severe side effects.

Eligibility criteria:
inclusion criteria: * diagnosis of platinum-sensitive recurrence of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer * the following histologic subtypes are eligible: papillary serous, endometrioid, mucinous, clear cell, adenocarcinomas, transitional, and mixtures of the above. * at least one measurable lesion according to recist criteria via ct or mri scan * received a platinum-containing regimen at initial diagnosis * ecog performance status of 0,1 or 2 * 18 years of age or older * life expectancy of greater than 12 weeks * wbc \> 1,500/mm3 * neutrophils \> 1,500/mm3 * platelets \> 100,000/mm3 * total bilirubin \< 1.5 uln * calculated creatinine clearance \> 45 ml/min * alt/ast \< 3 x uln (no liver mets) alt/ast \< 5 x uln (with liver mets) * complete recovery from completion of previous chemotherapy or biologic therapy * negative pregnancy test and agree to practice effective method of birth control exclusion criteria: * patients with sarcomatous, stromal, or germ cell elements * prior pelvic radiotherapy \> 25% of bone marrow * uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs * past history of bone marrow transplantation or stem cell support * known history of cns metastasis unless the patient has had treatment with surgery or radiation therapy, is neurologically stable, and does not require oral or intravenous corticosteroids or anticonvulsants * prior malignancy except adequately treated carcinoma in situ of the uterine cervix, incidental stage i endometrial cancer, basal cell or squamous cell skin cancer or breast cancer (invasive or ductal carcinoma in situ) of which the patient has been disease-free for at least five years * routine prophylactic use of g-csf or gm-csf or blood transfusions within 2 weeks * clinically significant cardiac disease as defined by: history of unstable angina within 6 months; history of symptomatic ventricular arrhythmias; history of congestive heart failure; history of myocardial infarction within 6 months * uncontrolled hypercalcemia or diabetes mellitus * any signs of intestinal obstruction with bowel function and/or nutrition * grade 2 or greater peripheral neuropathy * participation in an investigational study within three weeks * history of anaphylactic shock to prior platinum chemotherapy * history of psychiatric disability or other central nervous system disorder

Keywords: platinum-sensitive recurrence carboplatin pemetrexed